Senior Product Manager jobs at Navitus

Company Navitus About Us Navitus - Putting People First in Pharmacy - Navitus was founded as an alternative to traditional pharmacy benefit manager (PBM) models. We are committed to removing cost from the drug supply chain to make medications more affordable for the people who need them. At Navitus, our team members work in an environment that celebrates diversity, fosters creativity and encourages growth. We welcome new ideas and share a passion for excellent service to our customers and each other._____________________________________________________________________________________________________________________________________________________________________________________________________________. Current associates must use SSO login option at ************************************ to be considered for internal opportunities. Pay Range USD $55,151.00 - USD $66,447.00 /Yr. STAR Bonus % (At Risk Maximum) 5.00 - Salaried Non-Management except pharmacists Work Schedule Description (e.g. M-F 8am to 5pm) M-F 8am to 5pm Remote Work Notification ATTENTION: Navitus is unable to offer remote work to residents of Alaska, Hawaii, Maine, Mississippi, New Hampshire, New Mexico, North Dakota, Rhode Island, South Carolina, South Dakota, West Virginia, and Wyoming. Overview Due to growth, we are adding an Assoc. Product Manager, eHealth to our team! The Assoc. Product Manager, eHealth (APM) will be responsible for tactical support of Navitus eHealth services, which include e-prescribing (eRx), electronic prior authorization (ePA) and real time prescription benefits (RTPB). The APM will report to and provide support to the Manager, Digital Health. The APM will assist with and identify solutions for system enhancements, stability, and quality by working with IT resources. The APM will work with the Manager, Digital Health to create and monitor metrics that ensure product accuracy and quality, vendor strategy and product management. The APM will work with the key functional areas to ensure quality product development, client support and data integrity. Tasks related to this role will include participation of certification testing with vendors alongside IT resources, assisting in oversight of system enhancements, assisting in creating business requirements, troubleshooting, developing, and reviewing requirements, oversight of some system support tasks, and facilitating enhancement requests. In coordination with the Health Strategies leadership, the APM will follow the team roadmap for long-term success and continuous improvements to Navitus' eHealth services. The APM will be responsible for tracking all eHealth transactions in Navitus systems, reviewing all eHealth invoices and transaction details from eHealth vendors, and producing eHealth transactions billing statements to Navitus clients that include fees and transaction details for each eHealth activity. The APM will assist in crafting presentations to clients and prospective clients that highlight the value of eHealth products. The APM will develop a deep understanding of industry standards and serve as a business and technical subject matter expert for the organization as they relate to eHealth products. Is this you? Find out more below! Responsibilities How do I make an impact on my team? Work with Health Strategies leadership to execute goals and objectives for Navitus eHealth products. Responsible for the timely completion of eHealth product reports for transaction data and billing for Finance and Customer Success teams. Develop and maintain internal eHealth product metrics. Assist IT support teams to execute on testing of system enhancements, test cases, managing defects, and documenting results within required timeframes. Leverage competitive intelligence and evolving industry best practices to define and steer Navitus' products to be an industry leading solution. Work closely with Health Strategies leadership to ensure detailed requirements meet the needs of the business. Ensure that system enhancements, testing issues, and information about ePrescribing, ePA and real-time prescription benefits are communicated timely to the Manager, Digital Health and IT team. Troubleshoot for system issues or questions. Work with Health Strategies leadership to ensure controls are in place that adequately assess system quality and stability. Work with end users to suggest enhancements to the system or workflow processes to meet the needs of the business. Assist leadership in documenting requirements for new processes, services, and changes to existing processes to achieve department business and strategic goals. Assist leadership in oversight of setup and maintenance of system configuration. Assist with IT after-hours support as needed. Other duties as assigned. Qualifications What our team expects from you? Bachelor's degree or equivalent work experience is preferred. Experience in product management, formal/informal leadership and team collaboration/relationship-building management is essential. Experience in healthcare, pharmacy benefit management (PBM), biomedical, or digital health industries is preferred. Experience with program audits and quality is preferred. Participate in, adhere to, and support compliance program objectives. The ability to consistently interact cooperatively and respectfully with other employees. What can you expect from Navitus? Top of the industry benefits for Health, Dental, and Vision insurance 20 days paid time off 4 weeks paid parental leave 9 paid holidays 401K company match of up to 5% - No vesting requirement Adoption Assistance Program Flexible Spending Account Educational Assistance Plan and Professional Membership assistance Referral Bonus Program - up to $750! #LI-Remote Location : Address Remote Location : Country US

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. **The Position** PTT (MSAT & Engineering) is responsible for ensuring that PT stays at the forefront of technology in our facilities and supports our robust processes & efficient operations. We focus on integrating product health, process health with equipment fit for purpose, and facility readiness in support of the manufacturing network. Within PTT, Roche's global Manufacturing Science and Technology (gMSAT) department is the process and product owner for our commercial products, including our internal and external drug substance and drug product network, implementation of new technologies, network standardization, and mitigation of technical risks. The team is organized by product-focused Large Molecule and Small Molecule (DS & DP), Technology and Network Standards and Operations (Process Stewards, Tech Deployment, and Pilot Plant) teams and operates in cross-functional squads and circles. **The Opportunity** The Principal Large Molecule DP Product Steward is responsible for driving seamless technical industrialization and sustaining and improving the technical health of commercial products, starting from manufacturability decision through process performance qualification (PPQ), supply maturity and optimization, and ultimately divestment. Your main responsibilities cover Technical Industrialization (Develop Technical Strategic Roadmap), Product Technical Health Management (Own & Mitigate Technical Risks) and Technical Leadership: + Identify, define, and deliver DP-related technical industrialization strategies and technical improvements to ensure successful launch as well as that the product remains validated, robust, cost-effective, and compliant + Deliver on the product's technical strategic roadmap across the commercial lifecycle, as defined by an end-to-end Product Technical Lead, which includes investigating and mitigating technical risks, implementing improvements, and aligning strategies with broader network objectives + For resilient or established products in "steady state", take on an extended role to fully represent and deliver on the technical agenda where no end-to-end Product Technical Lead is assigned. In these cases, the technical product steward holds primary accountability for ensuring DP product quality, reliability, and the execution of long-term strategic goals and operational targets through the effective direction and management of a matrixed team and financial resources + Serve as a primary product technical owner for site leadership and quality functions when investigating product or process issues across the commercial lifecycle + Represent the product in key technical governance forums and senior stakeholder interactions **Who you are** The ideal candidate is a recognized authority in the field, bringing deep scientific expertise, extensive industrial experience, and exceptional leadership capabilities. + B.S. or M.S. degree in a scientific discipline (biotechnology, pharmacy, biology etc. ), with at least 10+ years of relevant industrial experience in platform specific process development or in supporting platform specific manufacturing operations (e.g. DS Bio, DP SM etc.), PhD is of advantage + Proven record in Drug Product manufacturing and product and technology industrialization as well as process development in the field of biological molecules. + Significant cross-functional matrix leadership experience + Demonstrated experience with technology transfer and/or with process validation + Strong understanding of regulatory submission and health authority requirements as well as patient needs / patient-centricity as key elements of design and delivery Ready for the next step? We look forward to hearing from you. Apply now to discover this exciting opportunity! Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Basel. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process. **Who we are** A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let's build a healthier future, together. **Roche is an Equal Opportunity Employer.**

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position PTT (MSAT & Engineering) is responsible for ensuring that PT stays at the forefront of technology in our facilities and supports our robust processes & efficient operations. We focus on integrating product health, process health with equipment fit for purpose, and facility readiness in support of the manufacturing network. Within PTT, Roche's global Manufacturing Science and Technology (gMSAT) department is the process and product owner for our commercial products, including our internal and external drug substance and drug product network, implementation of new technologies, network standardization, and mitigation of technical risks. The team is organized by product-focused Large Molecule and Small Molecule (DS & DP), Technology and Network Standards and Operations (Process Stewards, Tech Deployment, and Pilot Plant) teams and operates in cross-functional squads and circles. The Opportunity The Principal Large Molecule DP Product Steward is responsible for driving seamless technical industrialization and sustaining and improving the technical health of commercial products, starting from manufacturability decision through process performance qualification (PPQ), supply maturity and optimization, and ultimately divestment. Your main responsibilities cover Technical Industrialization (Develop Technical Strategic Roadmap), Product Technical Health Management (Own & Mitigate Technical Risks) and Technical Leadership: * Identify, define, and deliver DP-related technical industrialization strategies and technical improvements to ensure successful launch as well as that the product remains validated, robust, cost-effective, and compliant * Deliver on the product's technical strategic roadmap across the commercial lifecycle, as defined by an end-to-end Product Technical Lead, which includes investigating and mitigating technical risks, implementing improvements, and aligning strategies with broader network objectives * For resilient or established products in "steady state", take on an extended role to fully represent and deliver on the technical agenda where no end-to-end Product Technical Lead is assigned. In these cases, the technical product steward holds primary accountability for ensuring DP product quality, reliability, and the execution of long-term strategic goals and operational targets through the effective direction and management of a matrixed team and financial resources * Serve as a primary product technical owner for site leadership and quality functions when investigating product or process issues across the commercial lifecycle * Represent the product in key technical governance forums and senior stakeholder interactions Who you are The ideal candidate is a recognized authority in the field, bringing deep scientific expertise, extensive industrial experience, and exceptional leadership capabilities. * B.S. or M.S. degree in a scientific discipline (biotechnology, pharmacy, biology etc. ), with at least 10+ years of relevant industrial experience in platform specific process development or in supporting platform specific manufacturing operations (e.g. DS Bio, DP SM etc.), PhD is of advantage * Proven record in Drug Product manufacturing and product and technology industrialization as well as process development in the field of biological molecules. * Significant cross-functional matrix leadership experience * Demonstrated experience with technology transfer and/or with process validation * Strong understanding of regulatory submission and health authority requirements as well as patient needs / patient-centricity as key elements of design and delivery Ready for the next step? We look forward to hearing from you. Apply now to discover this exciting opportunity! Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Basel. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process. Who we are A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let's build a healthier future, together. Roche is an Equal Opportunity Employer.

Requisition ID: 63705 Title: Clinical Product Manager - Global Endoscopy Division: Arthrex, Inc. (US01) Location: Remote Salary Range: Salary Minimum: $94,500 Salary Maximum: $170,000 This position is remote, with travel primarily to West Coast. The ideal candidate will be based in the Western US. Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Clinical Product Manager to manage and lead our initiatives within the Global Endoscopy portfolio. The successful candidate will build relationships with key customers and internal departments to help drive new product innovation and manage product lines. Excellent interpersonal and leadership skills along with a Bachelor's degree and five years of experience are essential for this position. The position is remote to be based in our West coast or Northeast regions and does require frequent travel. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better. Main Objective: The Clinical Product Manager will be responsible for overseeing and managing the Multi-specialty imaging solution - focusing on fluorescence and additional visualization modalities sales opportunities, performance, training, and other activities with the sales force, surgeons, and accounts within his/her respective region. In addition, candidate is expected to forge new relationships with bio science partners focused on advanced visualization. Essential Duties and Responsibilities: * Ensure all IR Managers are trained to a high standard on anatomy, procedures and fluorescence science. * Manage clinical studies/research papers related to fluorescence imaging. * Assist IR Managers, Capital Managers & representatives with evaluation and closing activities with key customers and reporting back to Imaging and Resection Managers as it relates to advanced visualization. * Training representatives on advanced visualization and fluorescence solutions and sales cycle as needed. * Assist Imaging and Resection Sales Management in implementing sales playbook and execution of strategy. * Lead interaction with General, Urology, GYN, ENT and Thoracic surgeons to expand brand awareness of the Synergy solutions. Assist Ortho surgeons in fluorescence imaging discovery. * Manage entire sales pipeline to monitor health of the business and maximize closure rate and success. * Communicate sales opportunities to the Director - Global Endoscopy, Imaging and Resection Sales Management and Product Management. * Communicating product attributes and shortcomings to product managers and recommending product line enhancements. * Collecting key competitive information and ensuring that knowledge drives both sales effectiveness and product development direction. * Coaching, teaching, and when necessary directing opportunities to via conference calls and in person visits on products/sales strategy/competitive info. * Engage current and identify new Key Opinion Leaders for Local, Regional, and national peer to peer interactions. * Lead the submittal of RFP and tender responses working with regional and agency sales managers. * Up to 60% Travel. Education and Experience: * Bachelors degree required; MBA preferred. * Five years medical device sales or product management experience required, preferably in laparoscopic surgery. * Experience in the field with Endoscopy insufflation and fluorescence in Sales/Marketing required. * Experience at C-Suite level negotiations required. Knowledge and Skill Requirements/Specialized Courses and/or Training: * Willing to travel up to 60 % to sales presentations, trials, evaluations, demos, tradeshows, and customer meetings. * Knowledge of advanced surgical video and integration. * Skilled in working with different functions and effectively coordinates their activities to achieve desired results. * Excellent listening skills, including the ability to identify and isolate customers concerns or objections, in addition to excellent written and oral communication skills. * Strong relationship building skills desired. Arthrex Benefits * Medical, Dental and Vision Insurance * Company-Provided Life Insurance * Voluntary Life Insurance * Flexible Spending Account (FSA) * Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness) * Matching 401(k) Retirement Plan * Annual Bonus * Wellness Incentive Program * Gym Reimbursement Program * Tuition Reimbursement Program * Trip of a Lifetime * Paid Parental Leave * Paid Time Off * Volunteer PTO * Employee Assistance Provider (EAP) All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law. Making People Better at Arthrex Lorem ipsum dolor sit amet consectetur. Cras fringilla elementum odio velit. Job Details Date: Dec 15, 2025 Requisition ID: 63705 Salary Range: Job title: Clinical Product Manager - Global Endoscopy Arthrex Location: Remote, US, 34108 Nearest Major Market: Naples Job Segment: Product Manager, Gastroenterology, Medical Research, Clinic, Operations, Healthcare, Marketing

SummaryJob Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. As Associate Product Manager, Upstream, PI Vascular, you will be responsible for the innovation strategy of assigned products and spaces in conjunction with R&D, Clinical, Downstream Marketing, and other functions. You will be accountable for identifying unmet needs, market analysis, market research, and commercial deliverables for new product development. Candidates will be expected to be onsite in our Tempe, Arizona offices 4 days per week (Monday-Thursday) with the option to work remote most Fridays. Essential Job Functions: Work with R&D to develop a strong portfolio of product development projects that support the strategic direction and grow the business. Build relationship with and know key customers/distributors and major buying groups. Take an active role on product development teams as leader or key participant. Communicate with domestic sales force and global marketing entities (directly and through international marketing). Identify and communicate market trends to division management and internal “team.” Develop and implement comprehensive product marketing plans including strategic and technical components. Forecast sales volume, monthly and long-term. Budget administration (promotional and expense). Profit and loss responsibility for product line. Identify and develop marketing programs, sales tools and promotions. Assist in preparing Business Plans. Recommend product line modifications, extensions, new products and product deletions. Requirements: Bachelor's degree required (Business Administration, Marketing, Engineering, or relevant field); Master's degree preferred. Minimum of 3 years proven experience with a minimum of 2 years in product management; candidates will preferably have experience in medical device or pharmaceutical industries. Strong analytical abilities with proficiency in data interpretation and statistical analysis. Excellent communication and interpersonal skills, with the ability to build strong relationships internally and externally. Detail-oriented approach with a focus on accuracy and quality assurance. Ability to work independently and collaboratively in a fast-paced environment. Knowledge of FDA regulations governing medical devices and promotion of prescription drugs preferred. Familiarity with medical terminology and clinical trial methodologies preferred. Ability to travel up to 20%, including international travel as needed. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Required Skills Optional Skills . Primary Work LocationUSA AZ - Tempe HeadquartersAdditional LocationsWork Shift

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. **** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. + Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies and commercial supply. + Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability). + Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities. + Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures. + Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements. **Qualifications** Required + Bachelor's degree in Chemistry, Biology, Engineering or related Science. + Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products. + Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing). + Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing. + Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner. + Experience in using MS Office (Word, Excel, PowerPoint). + Experience in using TrackWise. + Excellent interpersonal and communication skills. + Technical Writing Experience: writing Investigations and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience with Pre Approval Inspections for NDAs and BLAs. + Analytical problem solving and decision-making skills. + Ability to identify gaps/risks and propose corrective and preventative actions. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Experience with quality oversight of controlled substances. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. **** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. + Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies and commercial supply. + Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability). + Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities. + Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures. + Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements. **Qualifications** Required + Bachelor's degree in Chemistry, Biology, Engineering or related Science. + Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products. + Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing). + Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing. + Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner. + Experience in using MS Office (Word, Excel, PowerPoint). + Experience in using TrackWise. + Excellent interpersonal and communication skills. + Technical Writing Experience: writing Investigations and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience with Pre Approval Inspections for NDAs and BLAs. + Analytical problem solving and decision-making skills. + Ability to identify gaps/risks and propose corrective and preventative actions. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Experience with quality oversight of controlled substances. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others. Position Summary: This position will report to the Senior Director of Drug Product Development and will be managing the activities related to preformulation, biopharmaceutics, formulation development from Phase 1 to commercial launch. This individual will be an integral part of the company's effort to discover and develop therapeutics for rare endocrine disorders and endocrine-related tumors. Essential Job Functions and Responsibilities: These may include but are not limited to: * Integrate biopharmaceutics principles to guide drug product design and development, ensuring clinically meaningful formulation strategies. * Design and develop formulation and processes to enable clinical studies with the desired performance. * In collaboration with DMPK and Clinical Pharmacology, develop and apply advanced modeling-informed strategies (e.g., PBPK) to predict drug dissolution, absorption, bioavailability, enabling formulation optimization, bridging decisions, and risk mitigation. * Design and execute experiments for development of rational, scientifically sound, phase appropriate formulations and manufacturing processes including biorelevant conditions to simulate in vivo performance. * Utilize software tools such as GastroPlus to model gastrointestinal physiology and inform formulation decisions. * Apply deep understanding of physiological factors (e.g., GI pH, transit times, regional absorption) to interpret human and animal clinical data, linking dissolution behavior to in vivo drug performance and guiding formulation refinement. * Contribute biopharmaceutics expertise to regulatory submissions, including IVIVC (In Vitro-In Vivo Correlation) and MIDD (Model-Informed Drug Development). * Stay current with advancements in predictive modeling, dissolution testing methodologies, and regulatory requirements. * Plan, direct, and oversee formulation, process development, manufacturing, and packaging activities at contract development and manufacturing organizations (CMOs). * Evaluate and select external partners for drug product development and manufacturing. * Prepare Drug Product development and manufacturing timelines and set clear deliverables for projects * Prepare and review request of proposal (RFPs), statements of work (SOWs), and associated budgets. * Prepare and review regulatory filings (IBs, INDs, IMPDs, NDAs, briefing packages). * Author and review SOPs, technical reports, specifications, CAPAs, change controls, investigations, and deviations to ensure compliance with cGMP and company standards. Education and Experience: Required: * A PhD in Pharmacokinetics, Pharmaceutical Science, or a related field with at least 7 years of related technical experience in the small molecule biopharmaceutical industry. * Experience supporting regulatory submissions with biopharmaceutics expertise. * Expertise in PBPK modeling and pharmacokinetics, with proficiency in software tools such as GastroPlus, Phoenix WinNonlin, and Simcyp. * Strong knowledge of dissolution testing methodologies and ability to design experiments with accurate testing conditions. * Experience in applying biopharmaceutics principles to late-stage drug development and formulation optimization. * Familiarity with FDA, EMA, and ICH guidelines related to biopharmaceutics and predictive modeling. * Lead work experience in drug product development and clinical manufacturing for small molecules. * Understanding of cGMP requirements and ICH and regulatory guidance is preferred. * Excellent analytical, problem-solving, and communication skills. Physical Demands and Work Environment: Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities. Laboratory Activities, if applicable: Biology and chemical laboratory environments experience needed. Environmental health and safety requirements also apply. Travel: Travel may be required up to 15% of your time. Equal Opportunity Employer: Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws. Total Compensation: The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process. Salary Range The salary range for this position is: $154,000 - $192,000. In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others. Position Summary: This position will report to the Senior Director of Drug Product Development and will be managing the activities related to preformulation, biopharmaceutics, formulation development from Phase 1 to commercial launch. This individual will be an integral part of the company's effort to discover and develop therapeutics for rare endocrine disorders and endocrine-related tumors. Essential Job Functions and Responsibilities: These may include but are not limited to: Integrate biopharmaceutics principles to guide drug product design and development, ensuring clinically meaningful formulation strategies. Design and develop formulation and processes to enable clinical studies with the desired performance. In collaboration with DMPK and Clinical Pharmacology, develop and apply advanced modeling-informed strategies (e.g., PBPK) to predict drug dissolution, absorption, bioavailability, enabling formulation optimization, bridging decisions, and risk mitigation. Design and execute experiments for development of rational, scientifically sound, phase appropriate formulations and manufacturing processes including biorelevant conditions to simulate in vivo performance. Utilize software tools such as GastroPlus to model gastrointestinal physiology and inform formulation decisions. Apply deep understanding of physiological factors (e.g., GI pH, transit times, regional absorption) to interpret human and animal clinical data, linking dissolution behavior to in vivo drug performance and guiding formulation refinement. Contribute biopharmaceutics expertise to regulatory submissions, including IVIVC (In Vitro-In Vivo Correlation) and MIDD (Model-Informed Drug Development). Stay current with advancements in predictive modeling, dissolution testing methodologies, and regulatory requirements. Plan, direct, and oversee formulation, process development, manufacturing, and packaging activities at contract development and manufacturing organizations (CMOs). Evaluate and select external partners for drug product development and manufacturing. Prepare Drug Product development and manufacturing timelines and set clear deliverables for projects Prepare and review request of proposal (RFPs), statements of work (SOWs), and associated budgets. Prepare and review regulatory filings (IBs, INDs, IMPDs, NDAs, briefing packages). Author and review SOPs, technical reports, specifications, CAPAs, change controls, investigations, and deviations to ensure compliance with cGMP and company standards. Education and Experience: Required: A PhD in Pharmacokinetics, Pharmaceutical Science, or a related field with at least 7 years of related technical experience in the small molecule biopharmaceutical industry. Experience supporting regulatory submissions with biopharmaceutics expertise. Expertise in PBPK modeling and pharmacokinetics, with proficiency in software tools such as GastroPlus, Phoenix WinNonlin, and Simcyp. Strong knowledge of dissolution testing methodologies and ability to design experiments with accurate testing conditions. Experience in applying biopharmaceutics principles to late-stage drug development and formulation optimization. Familiarity with FDA, EMA, and ICH guidelines related to biopharmaceutics and predictive modeling. Lead work experience in drug product development and clinical manufacturing for small molecules. Understanding of cGMP requirements and ICH and regulatory guidance is preferred. Excellent analytical, problem-solving, and communication skills. Physical Demands and Work Environment: Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities. Laboratory Activities, if applicable: Biology and chemical laboratory environments experience needed. Environmental health and safety requirements also apply. Travel: Travel may be required up to 15% of your time. Equal Opportunity Employer: Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws. Total Compensation: The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process. Salary Range The salary range for this position is: $154,000 - $192,000. In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.

A245 - 4B The Senior Product Marketing Manager is responsible for developing and executing marketing strategies for assigned products to drive product performance, market share, and profitability. This role requires a deep understanding of the pharmaceutical market, including the commercialization process, pricing strategies, payor access strategies, and the management of products through various lifecycle stages. The individual will translate scientific and clinical data into compelling marketing plans and work closely with cross-functional teams such as Sales, Payor Access, Patient Services, Regulatory, Legal and Medical Affairs to ensure compliance and alignment with corporate goals. This role as a member of the Portfolio Strategy Marketing team will require contributions and leadership to annual integrated business plan development with associated product forecasts, OPEX and commercial strategies to achieve annual business objectives. Incorporating payor access information with specific data-driven account information and marketing dynamics will be critical to the development of marketing segmentation strategies for tactical investment. ** This is a remote position. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Essential Duties & Responsibilities Strategy Development: Design and implement comprehensive brand marketing strategies for assigned product(s), ensuring that strategies align with business objectives and defined market and channel opportunities. Life Cycle Management: Manage product(s) throughout their lifecycle, from market introduction through maturity and potential loss of exclusivity, ensuring continuous optimization of market performance, profitability, and competitive positioning. Identification of new indications, new business channels or new formulations is very important. Pricing Strategy & Market Access: Collaborate with Market Access to develop pricing strategies consistent with the brand value proposition & key stakeholder dynamics. Manage the P&L including pricing with a focus on maintaining profitable market access. Market Research & Competitive Intelligence: Conduct ongoing market research, competitor analysis, and customer insights to inform product positioning and strategy adjustments. Monitor changes in market trends, competitor product launches, and regulatory changes. KOL & Physician Engagement: Develop and maintain relationships with Key Opinion Leaders (KOLs) and physician advocates to support brand messaging, clinical differentiation, and overall product success. Oversee the organization of advisory boards, speaker programs, and educational symposia in collaboration with Medical Affairs, Legal and other key commercial disciplines. Digital and Multi-Channel Marketing: In collaboration with the Marketing Execution team, drive the implementation of digital and multichannel marketing strategies, including social media, email marketing, and online advertising to enhance product visibility and engagement with healthcare professionals. Product Forecasting & Budget Management: In collaboration with rare disease commercial disciplines and leadership, lead the creation of annual revenue forecasts with key demand assumptions. Ensure knowledge of and ability to make investment decisions in alignment with P&L management. Collaborate with finance teams to optimize budget allocation across marketing activities. Cross-Functional Collaboration: Act as the brand lead and work collaboratively with internal teams such as Marketing Execution, Medical, Regulatory, Legal, Patient Services, and Sales to ensure successful product commercialization and delivery to market. Vendor Management: Oversee the selection and management of external vendors for marketing research, creative agencies, digital marketing, and promotional activities. Ensure projects are delivered on time, within budget, and aligned with strategic objectives. Performance Tracking & Adjustments: Monitor product performance metrics such as sales, market share, and profitability. Adjust marketing plans and tactics based on real-time data and market conditions to maximize brand success. The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. Experience Type Bachelor's degree in with a business concentration (Marketing, Finance) or in health sciences. An MBA is preferred. Minimum 8 years of professional marketing experience ideally within the pharmaceutical industry. Medical device and diagnostic experience would also be considered. Previous experience in payor access / channel marketing or other commercial disciplines. Demonstrated success in leading the development of integrated brand business strategies across commercial disciplines. Previous pharmaceutical launch experience. Strong strategic marketings skills with demonstrated ability to translate clinical data into multi-channel messaging anchored to the brand positioning statement. Ability to develop insights from secondary data, primary research and qualitative information to support alignment on commercial strategic options. Strong interpersonal skills and the ability to work with individuals across all organizational levels - with the ability to articulate thoughts clearly and concisely in writing and through presentations. Previous experience influencing cross-functional teams and mentoring team members in a marketing capacity. Excellent organizational skills and the ability to work on multiple projects simultaneously while under pressure. Proficient with Microsoft Office and familiar with software products pertaining to market analysis (IQVIA), data analysis and reporting. Other Knowledge, Skills and Abilities Understands the commercial and public sector payor landscape, including the impact of formularies, pricing and reimbursement strategies and the need for a concise brand value proposition to support product commercialization. Excellent communication and leadership skills with the ability to influence cross-functional teams and external stakeholders. Analytical mindset with the ability to derive insights from data and make strategic adjustments to improve product performance. Knowledge of digital marketing, CRM systems, and multi-channel marketing strategies to engage healthcare professionals and patients effectively. Strong project management skills, including experience managing budgets, timelines, and external vendors. Experience working in rare disease. Travel up to 25%. Compensation Range: $121,954.00 - $182,931.00 Upsher-Smith Laboratories, LLC is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Upsher-Smith Laboratories, LLC will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. **** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. + Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies and commercial supply. + Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability). + Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities. + Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures. + Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements. **Qualifications** Required + Bachelor's degree in Chemistry, Biology, Engineering or related Science. + Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products. + Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing). + Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing. + Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner. + Experience in using MS Office (Word, Excel, PowerPoint). + Experience in using TrackWise. + Excellent interpersonal and communication skills. + Technical Writing Experience: writing Investigations and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience with Pre Approval Inspections for NDAs and BLAs. + Analytical problem solving and decision-making skills. + Ability to identify gaps/risks and propose corrective and preventative actions. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Experience with quality oversight of controlled substances. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. **** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. + Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies and commercial supply. + Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability). + Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities. + Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures. + Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements. **Qualifications** Required + Bachelor's degree in Chemistry, Biology, Engineering or related Science. + Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products. + Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing). + Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing. + Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner. + Experience in using MS Office (Word, Excel, PowerPoint). + Experience in using TrackWise. + Excellent interpersonal and communication skills. + Technical Writing Experience: writing Investigations and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience with Pre Approval Inspections for NDAs and BLAs. + Analytical problem solving and decision-making skills. + Ability to identify gaps/risks and propose corrective and preventative actions. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Experience with quality oversight of controlled substances. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. **** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. + Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies and commercial supply. + Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability). + Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities. + Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures. + Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements. **Qualifications** Required + Bachelor's degree in Chemistry, Biology, Engineering or related Science. + Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products. + Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing). + Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing. + Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner. + Experience in using MS Office (Word, Excel, PowerPoint). + Experience in using TrackWise. + Excellent interpersonal and communication skills. + Technical Writing Experience: writing Investigations and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience with Pre Approval Inspections for NDAs and BLAs. + Analytical problem solving and decision-making skills. + Ability to identify gaps/risks and propose corrective and preventative actions. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Experience with quality oversight of controlled substances. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. **** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. + Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies and commercial supply. + Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability). + Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities. + Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures. + Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements. **Qualifications** Required + Bachelor's degree in Chemistry, Biology, Engineering or related Science. + Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products. + Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing). + Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing. + Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner. + Experience in using MS Office (Word, Excel, PowerPoint). + Experience in using TrackWise. + Excellent interpersonal and communication skills. + Technical Writing Experience: writing Investigations and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience with Pre Approval Inspections for NDAs and BLAs. + Analytical problem solving and decision-making skills. + Ability to identify gaps/risks and propose corrective and preventative actions. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Experience with quality oversight of controlled substances. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

We are seeking a Senior Technical Product Lead to drive product and project leadership within a drug product contract manufacturing organization (CMO). This role supports programs from initial facility fit assessment and technology transfer through client interaction, process improvements, validation, and commercial manufacturing. The Technical Product Lead will be part of the MS&T (Manufacturing Science & Technology) group, leading client interactions, internal project management, and technical and business process improvements. This position is fully on-site at our facility in Costa Mesa, CA. Key Responsibilities: New Product Introduction: Lead and contribute to proposal writing and review. Conduct facility fit assessments for new manufacturing programs, including risk assessments, failure mode analyses, and process impact evaluations. Oversee technology transfer activities between development and manufacturing. Translate process development reports into manufacturing batch records and SOPs. Provide hands-on manufacturing process training as part of technology transfer. Project Management: Develop and lead process improvement projects. Implement systems for improved GMP planning, scheduling, and execution. Oversee the lifecycle management of clinical and commercial programs. Develop and manage comprehensive project plans, sharing key deliverables with internal and external stakeholders. Serve as a primary client liaison, ensuring high-quality contract manufacturing services. Act as a technical interface between internal teams and client partners. Quality & Compliance: Support root cause investigations and CAPA (Corrective and Preventive Actions) implementation. Author and manage change control for internal and client-related projects. Drive operational excellence in collaboration with Manufacturing by identifying and implementing process improvements. Qualifications: Bachelor's Degree in Sciences or Engineering or equivalent experience. 8 years of experience supporting biotech or pharmaceutical manufacturing operations. Experience with aseptic operations and drug product manufacturing is required. 5 years of experience in project management within a biotech, pharmaceutical, or CMO setting. Strong understanding of GMP regulations and compliance within manufacturing facilities. Ability to analyze and improve manufacturing process data. Excellent written and verbal communication skills (technical writing ability required). Ability to work cross-functionally within internal and external teams to drive project success. Self-motivated, adaptable, and comfortable in a fast-paced contract manufacturing environment. Able to manage multiple projects simultaneously, ensuring on-time delivery and customer satisfaction.

The Director, External Expert Strategy & Engagement is a critical role responsible for defining, standardizing, and overseeing the company's global strategy for engaging a broad spectrum of external stakeholders. This includes Key Opinion Leaders (KOLs), Digital Opinion Leaders (DOLs), Payers/Access Stakeholders, Academic/Integrated Health Systems, Patients/Caregivers, and Patient Advocacy Groups. The role is accountable for establishing the governance, process clarity, and technological infrastructure necessary to ensure coordinated, high-value, and non-transactional interactions across all functional areas, distinguishing tactics based on the asset lifecycle stage (Early vs. In-line). This position reports directly to the Executive Director of External Engagement and Field Excellence. **** **Key Responsibilities:** **Strategic Governance and Accountability** + Establish clear accountability and process ownership for all external expert engagement activities, defining roles and responsibilities across the Medical Affairs (GMA) function to address the current pain point of limited clarity on accountabilities and responsibilities. + Develop and implement a standardized global strategy for external engagement that distinctly tailors objectives based on asset lifecycle (e.g., Early Asset engagement must focus on obtaining input from KOLs and Payers on trial design and clinical/economic value). **System and Data Management** + Coordinate with stakeholder engagement liaisons (from GMA, Commercial, Clinical Development, Market Access, Patient Advocacy and Stakeholder Management, Corporate Communications, and Government Affairs) and IT to migrate multiple, overlapping stakeholder lists. + Drive process adherence for the consistent upkeep and governance of the centralized external stakeholder list, ensuring the database accurately tracks engagement across all categories of stakeholders (e.g., Patients/Caregivers, Academic Systems, Digital Opinion Leaders). + Champion the use of the centralized system to track all medical expert interactions, contact attempts, and strategic insights captured. **Coordination and Best Practices** + Facilitate connections between the designated primary stakeholder lead contact and any internal team member seeking subsequent outreach to prevent multiple concurrent communications and requests. + Encourage and mandate best practices for GMA preparation before any stakeholder outreach, ensuring all engagement is high-quality and strategically aligned. + Partner with the Training team to develop standardized training and resources for internal teams on proper engagement protocols, compliance guidelines, and use of the centralized Veeva system, highlighting the specific goals for engaging each stakeholder group. + Collaborate with Global Training Lead to coordinate any needed training on external engagement processes and/or capabilities. + Consider technology and AI to support workflow improvement. **Qualifications:** **Education and Experience:** + Advanced scientific or clinical degree is required (PharmD, MD, PhD, or equivalent). + Minimum of 8 - 10 years of progressive experience in the pharmaceutical or biotechnology industry, with at least 5 years in Global Medical Affairs, Strategic Operations, or an equivalent function focused on External Expert/KOL Engagement. + Proven experience in designing, implementing, and managing global engagement processes across multiple therapeutic areas and across different asset lifecycle stages. + Demonstrated success in leading a complex cross-functional project (e.g., system migration, process standardization) involving IT and multiple business units. **Skills and Competencies:** + Exceptional ability to drive process governance and change management across a global matrix organization. + Superior Stakeholder Management and influencing skills, capable of gaining consensus and driving compliance among diverse functional leaders (Commercial, Clinical, Global Medical Affairs). + Strong technological acumen with proven experience working with Veeva or similar management platforms for centralized data management. + Excellent communication and presentation skills, with the ability to articulate the strategic value of coordinated external engagement to senior executive leadership. + Motivated and solution-oriented, with a clear focus on simplifying complex processes for end-users. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $183,335.00 - Maximum $274,160.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

As the Director of Global Marketing (Nephrology & Immunology), you will transform science into strategy by driving global brand strategy, influencing launch preparations and execution, and forging connections across the enterprise **. This role is responsible for the launch of a first-in-class monoclonal antibody within the Nephrology & Immunology portfolio** . A successful candidate must be a strong matrix leader, good communicator and well-rounded global commercial leader, with proven results in shaping and implementing brand strategy, creating and delivering impactful and innovative Global programs to excel performance across the Globe. Clear strategic thinking with the ability to lead and demonstrate passion for the brand is required. You'll join an empowered, fast-paced, high-visibility team at the forefront of scientific innovation, where your work will shape decisions that impact patients worldwide with autoimmune and rare diseases. **Responsibilities:** + **Global Launch Leadership & Market Preparation:** Lead cross-functional global launch planning, ensuring alignment across R&D, medical affairs, market access, and regional teams. Drive pre-launch excellence by preparing priority markets with tailored strategies, tools, and stakeholder engagement plans. Develop and execute global launch readiness frameworks, including asset-specific launch excellence scorecards and KPIs. Ability to manage a significant scope of responsibility including multiple indication launch plans and new assets. + **Global Congress & KOL Strategy:** Design and implement a global congress strategy that elevates scientific presence and brand visibility. Build and execute a global KOL engagement plan to cultivate advocacy, shape perception, and inform strategy. Partner with medical affairs to align scientific narratives and ensure consistent messaging across touchpoints. + **Strategic Asset Development & Lifecycle Planning:** Influence target product profiles and indication prioritization with a sharp eye on market differentiation and commercial viability. Co-chair the product development committee with R&D. Shape lifecycle strategies that maximize long-term value, from pre-launch through post-market expansion. Inform the annual Global Asset Planning Process and present to senior leadership. + **Cross-Functional & Regional Collaboration:** Serve as the strategic integrator across global and regional teams, ensuring seamless execution and shared accountability. Facilitate enterprise-wide alignment through structured planning processes and transparent communication. Lead Launch Readiness Reviews with regions as well as Global Brand Team meeting with regions around the globe. + **Budget & Resource Stewardship:** Own global marketing budgets for assigned assets, ensuring strategic investment and ROI-driven execution. **Qualifications** + 10+ years in pharmaceutical or biotech marketing, with deep experience in launch strategy and pre-launch planning, global preferred + Proven success leading cross-functional teams through late-stage development and global commercialization + Expertise in global congress planning, KOL strategy, and market readiness frameworks. + Strong strategic thinking, business case development, and stakeholder influence. + Experience in Nephrology, Immunology, or autoimmune therapeutic areas preferred. + Undergraduate degree in marketing, science, or business required; advanced degree (MBA, PharmD, PhD, MD) strongly preferred. + Location: Remote, with ability to be in Princeton, NJ for moments that matter + Willingness to travel up to 30% globally. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $183,335.00 - Maximum $274,160.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

As the Director of Global Marketing (Nephrology & Immunology), you will transform science into strategy by driving global brand strategy, influencing launch preparations and execution, and forging connections across the enterprise **. This role is responsible for the launch of a first-in-class monoclonal antibody within the Nephrology & Immunology portfolio** . A successful candidate must be a strong matrix leader, good communicator and well-rounded global commercial leader, with proven results in shaping and implementing brand strategy, creating and delivering impactful and innovative Global programs to excel performance across the Globe. Clear strategic thinking with the ability to lead and demonstrate passion for the brand is required. You'll join an empowered, fast-paced, high-visibility team at the forefront of scientific innovation, where your work will shape decisions that impact patients worldwide with autoimmune and rare diseases. **Responsibilities:** + **Global Launch Leadership & Market Preparation:** Lead cross-functional global launch planning, ensuring alignment across R&D, medical affairs, market access, and regional teams. Drive pre-launch excellence by preparing priority markets with tailored strategies, tools, and stakeholder engagement plans. Develop and execute global launch readiness frameworks, including asset-specific launch excellence scorecards and KPIs. Ability to manage a significant scope of responsibility including multiple indication launch plans and new assets. + **Global Congress & KOL Strategy:** Design and implement a global congress strategy that elevates scientific presence and brand visibility. Build and execute a global KOL engagement plan to cultivate advocacy, shape perception, and inform strategy. Partner with medical affairs to align scientific narratives and ensure consistent messaging across touchpoints. + **Strategic Asset Development & Lifecycle Planning:** Influence target product profiles and indication prioritization with a sharp eye on market differentiation and commercial viability. Co-chair the product development committee with R&D. Shape lifecycle strategies that maximize long-term value, from pre-launch through post-market expansion. Inform the annual Global Asset Planning Process and present to senior leadership. + **Cross-Functional & Regional Collaboration:** Serve as the strategic integrator across global and regional teams, ensuring seamless execution and shared accountability. Facilitate enterprise-wide alignment through structured planning processes and transparent communication. Lead Launch Readiness Reviews with regions as well as Global Brand Team meeting with regions around the globe. + **Budget & Resource Stewardship:** Own global marketing budgets for assigned assets, ensuring strategic investment and ROI-driven execution. **Qualifications** + 10+ years in pharmaceutical or biotech marketing, with deep experience in launch strategy and pre-launch planning, global preferred + Proven success leading cross-functional teams through late-stage development and global commercialization + Expertise in global congress planning, KOL strategy, and market readiness frameworks. + Strong strategic thinking, business case development, and stakeholder influence. + Experience in Nephrology, Immunology, or autoimmune therapeutic areas preferred. + Undergraduate degree in marketing, science, or business required; advanced degree (MBA, PharmD, PhD, MD) strongly preferred. + Location: Remote, with ability to be in Princeton, NJ for moments that matter + Willingness to travel up to 30% globally. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $183,335.00 - Maximum $274,160.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

As the Director of Global Marketing (Nephrology & Immunology), you will transform science into strategy by driving global brand strategy, influencing launch preparations and execution, and forging connections across the enterprise **. This role is responsible for the launch of a first-in-class monoclonal antibody within the Nephrology & Immunology portfolio** . A successful candidate must be a strong matrix leader, good communicator and well-rounded global commercial leader, with proven results in shaping and implementing brand strategy, creating and delivering impactful and innovative Global programs to excel performance across the Globe. Clear strategic thinking with the ability to lead and demonstrate passion for the brand is required. You'll join an empowered, fast-paced, high-visibility team at the forefront of scientific innovation, where your work will shape decisions that impact patients worldwide with autoimmune and rare diseases. **Responsibilities:** + **Global Launch Leadership & Market Preparation:** Lead cross-functional global launch planning, ensuring alignment across R&D, medical affairs, market access, and regional teams. Drive pre-launch excellence by preparing priority markets with tailored strategies, tools, and stakeholder engagement plans. Develop and execute global launch readiness frameworks, including asset-specific launch excellence scorecards and KPIs. Ability to manage a significant scope of responsibility including multiple indication launch plans and new assets. + **Global Congress & KOL Strategy:** Design and implement a global congress strategy that elevates scientific presence and brand visibility. Build and execute a global KOL engagement plan to cultivate advocacy, shape perception, and inform strategy. Partner with medical affairs to align scientific narratives and ensure consistent messaging across touchpoints. + **Strategic Asset Development & Lifecycle Planning:** Influence target product profiles and indication prioritization with a sharp eye on market differentiation and commercial viability. Co-chair the product development committee with R&D. Shape lifecycle strategies that maximize long-term value, from pre-launch through post-market expansion. Inform the annual Global Asset Planning Process and present to senior leadership. + **Cross-Functional & Regional Collaboration:** Serve as the strategic integrator across global and regional teams, ensuring seamless execution and shared accountability. Facilitate enterprise-wide alignment through structured planning processes and transparent communication. Lead Launch Readiness Reviews with regions as well as Global Brand Team meeting with regions around the globe. + **Budget & Resource Stewardship:** Own global marketing budgets for assigned assets, ensuring strategic investment and ROI-driven execution. **Qualifications** + 10+ years in pharmaceutical or biotech marketing, with deep experience in launch strategy and pre-launch planning, global preferred + Proven success leading cross-functional teams through late-stage development and global commercialization + Expertise in global congress planning, KOL strategy, and market readiness frameworks. + Strong strategic thinking, business case development, and stakeholder influence. + Experience in Nephrology, Immunology, or autoimmune therapeutic areas preferred. + Undergraduate degree in marketing, science, or business required; advanced degree (MBA, PharmD, PhD, MD) strongly preferred. + Location: Remote, with ability to be in Princeton, NJ for moments that matter + Willingness to travel up to 30% globally. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $183,335.00 - Maximum $274,160.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.